MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for FILSHIE CLIP manufactured by Unknown.
[181631904]
Reporter states soon after filshie clip implant, she started having left sided pain. Had multiple doctor visit because of pain. Lab works came out normal. Reporter states stomach bloating, hard time breathing, allergic reaction, difficulty thinking and remembering, bowel movement difficulty, body is reacting to the device negatively, can? T run any longer because of constant left sided sharp pain. In (b)(6) 2019, reporter was told by doctors that the device has come loose and migrated, reporter states she does not understand why doctors are refusing to take device out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093349 |
| MDR Report Key | 9764051 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2005-12-01 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE CLIP |
| Generic Name | LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-02-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |